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Patent Wars - Round two in favour of Novartis as Cipla unable to mount credible challenge

The two judges bench (division bench) of the Delhi High Court has upheld the decision of a single judge restraining Cipla from selling generic version of Novartis patent on respiratory drug containing 'INDACATEROL' or 'INDACATEROL Maleate' marketed under the name ONBREZ. Cipla challenged the decision on three main issues a) Novartis is not manufacturing the drug in India thus not making use of Patent b) public interest is not being served on account of import of a small quantity and price difference between Novartis and Cipla's drug c) right to restrain a third party from infringement (Section 48) is subject to working of Patent (Section 83).

Brief facts:

Cipla launched generic version of Novartis patented drug sold under the mark ONBREZ containing 'INDACATEROL' in October 2014.

Cipla had priced its generic versions of the drug, at Rs 130 per pack of ten tablets, compared with Rs 677 for Onbrez.

Novartis filed a suit for patent infringement seeking an injunction against Cipla's generic version of ONBREZ, alleging infringement of its patent over INDACETROL.

The single judge of Delhi High Court granted temporary injunction restraining Cipla from selling its generic version. At the same time giving Cipla liberty to have the injunction order modified if they file a petition for Compulsory license and it was decided in their favour.

Division Bench (DB) Ruling

Cipla Appealed the decision of single judge to two judges bench/ Division Bench of Delhi High Court. DB decided in favour of Novartis holding:

there was no credible challenge to Novartis patent, hence patentee is entitled to avail the benefit of injuncting any third party infringing its patent rights.

provisions of Section 83 of the Patent Act do not curtail the right of patentee to stop a party from infringing its rights under Section 48.

Manufacturing in India is not necessary to show working of a patent in India. Even imports will suffice the purpose.

Public Interest is only one of the factors while deciding the injunction. There has been no prima facie case to show that public service would be disserved by the grant of injunction in this case rather on the contrary, there is no credible challenge to the validity of Novartis patent.

that apart from INDACATEROL, there are other drugs which deal with the management of COPD which are also available in the Indian market. In addition INDACATEROL does not fall in the category of a life saving drug such as a cancer medicine.

To sum up:

The decision is noteworthy as it strikes the balance between public interest and exclusive rights conferred on the patentee. Further it makes clear that infringement provisions provided under Section 48 cannot be curtailed if there is no credible challenge to the Patent rights.

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